QM/RA Manager

  • Location

    Aschaffenburg, Germany

  • Sector:

    Regulatory Affairs

  • Salary:

    €60,000 - €80,000

  • Contact:

    Rebecca Stevens

  • Job ref:

    17760

  • Published:

    about 1 year ago

  • Expiry date:

    2020-06-08

QA/RA Manager (m / w / d)

Based in Bavaria, near Aschaffenburg

Our client is a privately-owned global leader in Ophthalmic medical devices. Due to product expansion, growth in new markets and the new European regulations, they are looking to strengthen their team with a QA/RA Manager, with a 80/20 focus on quality. This position will work closely with the Head of R&D, and the team of 30 offer a collaborative culture and an innovative working environment.

Your Responsibilities:

  • Ensures that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes
  • You review and approve device related development documentation by overseeing the design control process and the whole device related life cycle process
  • Participation in and performance of internal and external audits
  • Working to ISO 13485
  • Manage the verification and validation of the company software products and systems according to internal software lifecycle management processes

Experience Required:

  • 3-5 years of RA/QM experience at a Medical Device company (Ideally with expertise in Ophthalmic Devices)
  • Academic technical background, or from a Quality Engineering position
  • Experience in system validation and CSV would be a plus
  • Weighted focus on quality management systems to ISO 13485
  • Working with codes for risk (14971) software (62304) and electric (60601)
  • Experience in the MDD/MDR transition for Europe

 

Please apply with your CV or contact the job poster Rebecca Woodfield for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.

Rebecca.Woodfield@Adaptivelifescience.com

+44 208 638 5376